On Oct 22, 2010 the TGA posted on their website the following info: “The Therapeutic Goods Administration (TGA) and Health Canada (HC) are pleased to announce that the Memorandum of Understanding (MoU) on reciprocal recognition of quality management system (QMS)
FDA Modifications to List of Recognized Standards, List 025
On Oct 4, 2010 the Federal Register published the “Modifications to the List of Recognized Standards, Recognition List Number: 025“. This list will assist medical device manufacturers who elect to declare conformity with FDA Consensus Standards to meet certain FDA
EU AUS Med Dvc MRA but Mfr’s Be Careful
This Mutual Recognition Agreement on standards and conformity assessment between Australia and the European Community has been in effect since 1 Jan 1999. But the list of Conformity Assessment Bodies (CAB) for the EU doesn’t cover every EU Medical Device
NWIP – Collateral Std IEC60601-1-XX Emergency Med Srvcs
A New Work Item Proposal for Medical Electrical Equipment & Medical Electrical Systems used in the Emergency Medical Services Environment will be submitted to ISO by the end of November 2010. This proposed standard follows the structure of the Collateral
QuadTech 5th Ed. Electrical Safety Testing Guide
The QuadTech 5th Edition Electrical Safety Testing Guide is a useful document to help you understand the basics of Leakage Current and Dielectric Tests for 60601-1 and for additional standards. This document is a useful resource for understanding some of
